Validation Engineer - Allegan Area

We are working with companies in Allegan that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

• →Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• →Perform risk assessments and generate validation plans.
• →Analyze data, write validation reports, and present findings.
• →Investigate deviations and non-conformances during validation activities.
• →Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality systems.
• →Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• →Maintain validation documentation throughout the equipment and process lifecycle.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Demonstrated understanding of GxP, FDA regulations, and industry standards (e.g., ISO 13485).
• Experience authoring and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis and data interpretation for validation activities.

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, R, Python).
• Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
• Familiarity with Computer System Validation (CSV) principles and GAMP 5.
• Experience with risk management tools and methodologies (e.g., FMEA, PHA).
• Knowledge of cybersecurity best practices for industrial control systems.

Validation Engineer, QA Validation Engineer, Computer System Validation Engineer, CSV Engineer, Automation Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Assurance Validation Engineer

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.